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talc powder, sterile (Sclerosol Intrapleural Aerosol, Sterile Talc Powder)

 

Classes: Sclerosing Agents

Dosing and uses of Sclerosol (talc powder, sterile)

 

Adult dosage forms and strengths

aerosol powder

  • 4g

suspension reconstituted

  • 5g

 

Malignant Pleural Effusion

Indicated as a sclerosing agent to decrease malignant pleural effusion recurrence in symptomatic patients

Administered intrapleurally via chest tube after adequate drainage of the effusion

Aerosol : 4-8 g (1-2 canisters); deliver by manually pressing actuator button; distal end of the delivery tube should be pointed in several different directions, while short bursts are administered to distribute talc powder equally and extensively on all visceral and parietal pleural surfaces

Powder: 5 g as single dose dispersed in sodium chloride injection 50 to 100 mL; doses range from 2 to 10.5 g shown to be effective

 

Pediatric dosage forms and strengths

Safety and efficacy not established

 

Sclerosol (talc powder, sterile) adverse (side) effects

Frequency not defined

Difficult to distinguish adverse effects of talc from adverse effects of procedures associated with talc administration

Empyema

Hypoxemia

Dyspnea

Unilateral pulmonary edema

Pneumonia

ARDs

Bronchopleural fistula

Hemoptysis

Pulmonary emboli

Tachycardia

Myocardial infarction

Hypotension

Hypovolemia

Asystolic arrest

Adverse reactions due to the delivery procedure and chest tube may include pain, infection at the site of thoracostomy or thoracoscopy, localized bleeding, and subcutaneous emphysema

 

Warnings

Contraindications

Hypersensitivity

 

Cautions

May preclude subsequent diagnostic procedures of the pleura on the treated side, in including ipsilateral lung resective surgery and pneumonectomy for transplantation purposes

No known antineoplastic activity and should not be used alone for potentially curable malignancies where systemic therapy would before appropriate; does not exhibit antineplastic therapy

May cause pulmonary complication (eg, acute pneumonitis, ARDS)

Keep Sclerosol (aerosol) away from any heat source that could cause it to explode

 

Pregnancy and lactation

Pregnancy category: B

Lactation: Not studied

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Sclerosol (talc powder, sterile)

Mechanism of action

Induces inflammatory reaction; this reaction promotes adherence of the visceral to the parietal pleura, thereby obliterating the pleural space and preventing reaccumulation of pleural fluid